Key Responsibilities:
• Provide process engineering services for the design, commissioning, and qualification of a major expansion to an existing bulk vaccine processing facility.
• Act as a client-owner representative within the Process Engineering Team to ensure successful project execution.
• Lead cross-functional teams to deliver:
1. Equipment package design, factory acceptance testing, installation, and commissioning.
2. Product vessels, single-use mixers, single-use UFDF skids, and CIP/SIP skids.
Job Responsibilities:
• Support the Process Lead in implementing a Process Design based on defined project requirements.
• Lead cross-functional teams to ensure project and site stakeholder inputs are accurately captured and reflected in commissioning and qualification (C&Q) deliverables.
• Ensure clear communication and alignment among project stakeholders regarding key process suite activities and decisions.
• Track and monitor progress of process suite team milestones and provide status reports.
• Oversee C&Q execution performed by partner firms and ensure adherence to global engineering standards and best practices.
• Coordinate and support C&Q field execution, including:
1. Development and review of system lifecycle documents (Criticality and Risk Assessments, FAT documentation, and C&Q documentation).
2. Management of installation, start-up, and testing of process systems through OQ completion.
3. Ensuring post-OQ readiness for Performance Qualification (PQ) and Process Performance Qualification (PPQ).
• Collaborate with stakeholders, equipment vendors, and business partners to ensure seamless integration of project components.
• Perform project engineering duties such as:
1. Preparation of schedules, work plans, and cost tracking for equipment.
2. Coordination of project activities between various stakeholders.
Education & Experience Requirements:
• Degree Qualification: Minimum B.Sc. or M.Sc./M.Eng in Chemical, Biochemical Engineering, or equivalent discipline. Equivalent qualifications include a Biotechnology or Industrial Chemistry degree with core chemical/biochemical engineering fundamentals.
• Experience: Minimum of 8 years of post-academic experience in biopharmaceutical process engineering, covering design, construction, and start-up.
Technical & Leadership Skills:
• Strong ability to lead and influence teams in a matrix organizational structure.
• Excellent communication, presentation, and organizational skills.
• In-depth understanding of process engineering and technologies relevant to bulk vaccine/biologics processing.
• Knowledge and application of single-use technologies.
• Familiarity with DCS/PLC process control platforms (e.g., Delta V) and industry SDLC methodologies.
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